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FDA 510(k)

GAMBRO PUMP CONSOLE CSL

K-Number: K822068 · 1982-08-24

ApplicantGambro, Inc.
Decision Date1982-08-24
Product CodeDTQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GAMBRO PUMP CONSOLE CSL is the device name listed in this FDA 510(k) record. The listed applicant is Gambro, Inc.. It received FDA 510(k) clearance on 1982-08-24 under 510(k) number K822068. The device is classified under product code DTQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMBRO PUMP CONSOLE CSL?

GAMBRO PUMP CONSOLE CSL is a medical device that received FDA 510(k) clearance on 1982-08-24. The listed applicant is Gambro, Inc.. The 510(k) number is K822068.

When did GAMBRO PUMP CONSOLE CSL receive FDA 510(k) clearance?

GAMBRO PUMP CONSOLE CSL received FDA 510(k) clearance on 1982-08-24, under 510(k) number K822068.

Who is the listed applicant for GAMBRO PUMP CONSOLE CSL?

The FDA 510(k) record lists Gambro, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GAMBRO PUMP CONSOLE CSL?

The FDA product code for GAMBRO PUMP CONSOLE CSL is DTQ.

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Other records listing Gambro, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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